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Final 1 project report - Template [Full Project Title] [Acronym] [Grant Agreement No] [Name of the scientific representative of the Coordinator] 2 [Coordinator Institution] [Coordinator Contact Details]

Last Period [month/year] - [month/year]

Reporting Period [number]

Duration of the project [start project month/year] - [end project month/year]

Description of work - [date/version]

Submission deadline

1

The Final project report also includes the periodic report of the last period (see Articles II.4 and II.4.2 of the IMI Model

Grant Agreement).

2 Usually the person mentioned in the coordinator A2.4 form (in SOFIA IT tool). (IMI Ref.

IMI/INT/2014-02186)

Declaration of the

coordinator I, the coordinator of the - project, declare that, The periodic report submitted is in line with the obligations as stated in Article 20 of the Grant

Agreement:

The attached periodic report represents an accurate description of the work carried out in this project for this reporting period;

The project (tick as appropriate):

deviations The public project website
is up to date, if applicable. To my best knowledge, the financial statements which are being submitted as part of this report are

in line with the actual work carried out and are consistent with the report on the resources used for

the project and if applicable with the certificate on financial statement. All participants have declared to have verified their legal status. Any changes or deviations have been reported to the Beneficiary Register, and to the IMI2 JU via the coordinator in accordance with Article 17.2 of the Grant Agreement.

Name of the Coordinator: Firstname Secondname

Date: dd Mmm YYYY

Signature of the Coordinator: ..................................

2

Table of content

Declaration of the coordinator ........................................................................4

1. Executive summary .............................................................................5

1.1. Project rationale and overall objectives of the project ........................................................... 5

1.2. Overall deliverables of the project .......................................................................................... 5

1.3. Summary of progress versus plan since last period................................................................. 5

1.4. Significant achievements since last report .............................................................................. 5

1.5. Scientific and technical results/foregrounds of the project .................................................... 5

1.6. Potential impact and main dissemination activities and exploitation of results ..................... 5

1.7. Lessons learned and further opportunities for research ......................................................... 5

2. Summary of progress against objectives ..............................................6

2.1. Summary table ......................................................................................................................... 6

2.2. Description of progress for delayed milestones/deliverables not completed partially

completed during the last reporting period ............................................................................ 6

2.3. Follow-up of recommendations and comments from previous review(s) (if applicable) ....... 6

2.4. Deviations from Description of Work during the last reporting period .................................. 6

2.5. Summary statement on all Work Packages ............................................................................. 7

3. Summary of Major Achievements and key dissemination activities .....8

3.1. Major achievements for the last reporting period .................................................................. 8

3.2. Key dissemination activities for the last reporting period ....................................................... 8

4. Summary of project outcomes ............................................................8

5. Research use and dissemination of Foreground ................................ 15

5.1. Current Status .............................................................................................................................. 15

5.2. Plan for Research use and dissemination of

Foreground ............................................................ 15

5.3. Plan for sustainability................................................................................................................... 20

6. Management of Project and Consortium ........................................... 20

7. Finance - Cost .................................................................................... 21

7.1. Cost summary for the last reporting period ................................................................................ 21

7.2. Description of deviation from original budget ............................................................................ 23

8. Form C and Summary Financial Report .............................................. 24

3

Declaration of the coordinator

I, the coordinator of this project, declare that,

The final report submitted is in line with the obligations as stated in Article II.2.3 of the Grant

Agreement:

The attached report represents an accurate description of the work carried out in this project for the last reporting period as well as for the whole duration of the project;

For the last period, the project

(tick as appropriate):

has fully achieved its objectives and technical goals; has achieved most of its objectives and technical goals for the period with relatively minor deviations

3 has failed to achieve critical objectives and/or is not at all on schedule 3

For the

whole duration of the project, the project (tick as appropriate): has fully achieved its objectives and technical goals; has achieved most of its objectives and technical goals with relatively minor deviations 3 has failed to achieve critical objectives and/or is not at all on schedule 3

The public

project website
4 is up to date. To my best knowledge, the financial statements which are being submitted as part of this final report are in line with the actual work carried out and are consistent with the report on the resources used for the project (section 7) and if applicable with the certificate on financial statement. All participants, in particular non-profit public bodies, secondary and higher education establishments, research organisations and SMEs, have declared to have verified their legal status. Any changes or deviations have been reported under section 6 (Project Management) in accordance with Article II.3.f of the Grant Agreement. Name of the Coordinator: ............................................................

Date: ............/ ............/ ............

Signature of the Coordinator: ...................................................... 3 If either of these boxes is ticked, the report should reflect these and any remedial actions taken. 4

Please add the address of the public project website. The home page of the website should contain the generic IMI

logo which is available in electronic format at the IMI website. The a rea of activity of the project should also be mentioned.

4

1. Executive summary

The executive summary will be made publically available, and therefore should not include information deemed as confidential by the consortium. It should be concise (preferably no more than

40 pages), comprehensive and should capture the updates for the last reporting period as well as the

overall outputs of the project and its impact. It shall at least cover the following items: 1.1. Project rationale and overall objectives of the project (max 1 page) 1.2.

Overall deliverables of the project

(max 1 page) 1.3.

Summary of progress versus plan since last period

(Any major deviations, risks should be highlighted in this section) 1.4.

Significant achievements since last report

1.5. Scientific and technical results/foregrounds of the project 1.6. Potential impact and main dissemination activities and exploitation of results

Please explain how the project scientific/technical outputs contribute to the overall IMI objectives:

- to provide socio-economic benefits for European citizens, - to contribute to the health of European citizens, - to increase the competitiveness of Europe and help to establish Europe as the most attractive place for biopharmaceutical research a nd development. Please outline how the project outputs have/will have the potential to be rapidly and broadly spread and taken up within the scientific/industrial community and healthcare professionals. 1.7. Lessons learned and further opportunities for research Please indicate how the collaboration in a public private partnership (PPP) has been an added value to achieve the objectives of the project. From your experience, please propose any recommendations/ solutions which could be useful for a PPP. In view of your project achievements, please provide your views on potential new research to further advance the field.

5

2. Summary of progress against objectives

2.1.

Summary table

Please include the complete list of all milestones and deliverables of the project including those due

for the last reporting period, and any outstanding ones from the previous reporting period(s). Description of the milestones/deliverables should be short and concise reflecting the status. Please align these milestones and deliverables with the objectives listed above.

Work -

Package

Number

Milestone/

Deliverable

Due Date

(Annex I- description of work)

Completed

(Yes/Not yet/Partially)

Dissemin.

level 5

Related document

attached (Yes/No/Not applicable)

2.2. Description of progress for delayed milestones/deliverables not completed

partially completed during the last reporting period

For those milestones and deliverables

"not completed-partially completed" for the last reporting period, please explain the reasons for non-completion and the impact on achieving the overall objectives of the project. Description should be no more than 1/2 page for each milestone/deliverabl e. [No further description is needed for the completed milestones/deliverables for which related document(s) listed in the table above has been provided]. 2.3. Follow-up of recommendations and comments from previous review(s) (if applicable) Include in this section the list of recommendations and comments from previous reviews and give information on how they have been followed up. 2.4. Deviations from Description of Work during the last reporting period (max 2 pages) 5

PU = Public, fully open, e.g. web CO = Confidential, restricted under conditions set out in Model Grant

Agreement CI = Classified, information as referred to in Commission Decision 2001/844/EC

6

In case of any

major deviations during the last reporting period, please provide the reason for such deviations as well as measures taken to achieve the objectives of the project. Please focus on major deviations which impact on success of the project, including budget. 2.5.

Summary statement on all Work Packages

For this final report, please provide a summary statement for each work package (max 3 pages for work-package). In case of major deviations, please explain.

7

3. Summary of Major Achievements and key dissemination activities

3.1.

Major achievements for the last reporting period

(max 1 page) For the last reporting period, please present the major achievements that really capture the impact of your project in adding to the knowledge in this research area using tangible results. Achievements should be described as a standalone success for the project e.g. major results in

publications, successful 'qualification for use' approval, successful course launch/completion as well

as feedback from attendees and raising awareness of patients. Please avoid repeating progress against milestones and deliverables. These major achievements may be used by the IMI JU t o communicate success stories. 3.2. Key dissemination activities for the last reporting period

Please report major activities undertaken during the last reporting period to disseminate the project

results including patent application, publications, abstracts, conferences, project website using the

table below and specify for each activity the target group (e.g. scientific community, patients' organisations, policy makers, the general public).

Nature of

Communication

Title Responsible Participant Date Target audience

4. Summary of project outcomes

Please fill the below table for your project. Some sections of the form may not be relevant to your

project. The information on your project will provide IMI with statistics and indicators on societal and

socio-economic issues addressed by projects. It will help to feed Key Performance Indicators (KPIs)

for the measurement of performance and results against strategic overarching priorities identified as

critical for overall success of IMI. The replies for individual project will not be made public.

Where appropriate

please document the resources produced by the project (with the exclusion of deliverable reports and publications) and where they are archived for the purpose of reproducibility/verifiability. If the resource is destroyed (e.g. bio samples) please indicate.

8

4.1. Project general information

Research area

Type of impact Methodology, model, tool, process, drug etc.

Stage in drug development

pathway Lead discovery, lead optimisation, Pre-clinical, clinical, manufacturing, etc.

4.2. Staff statistics

Please indicate in the table below the number of people who worked on the project (on a headcount basis).

Type of position

Number of Women Number of Men

Scientific Coordinator

Work Package leaders

Experienced researchers (i.e. PhD

holders)

PhD Students

Other

Number of personnel hired for the

project

Number of staff changing positions

within and between partners (staff mobility)

Specify organisations Specify organisations

4.3. Resource Input from the Project Partners

Number of

resources pooled

Size Unit

(data, samples subjects, compounds, etc.)

Comments

Data sets

6

Briefly describe resource

Biobanks

7

Briefly describe resource

Biologicals Samples

8

Briefly describe resource

Cohorts

9 / Patient registries 10

Briefly describe resource

Software

11

Briefly describe resource

Models, tools Briefly describe resource

Compounds Briefly describe resource

Other (please specify) Briefly describe resource 6

Any organised collection of data

7

A collection of biological material and the associated data and information stored in an organised system, for a

population or a large subset of a population. 8 A biological specimen including, for example, blood, tissue, urine, etc. taken from a participant. 9

A cohort is a group of persons who experience a certain event in a specified period of time. For example, the birth

cohort of 1985 would be the people born in that year. 10

An application which stores metadata for querying, and which can be used by any other application in the network

with sufficient access privileges. 11 Programmes, procedures and data associated with the operation of a computer system.

9

4.4. Resource Outputs of the project

Models, tools, technologies, molecules, protocols

Number/size and type Stage of

development Resource location and identifier, future maintenance

Provide unique identifier, DOI

or data citation

Biomarkers

Efficacy, safety, prognostic,

etc. Identified, validated, qualified, etc.

Preclinical models (in vitro) Standardised,

validated, qualified, etc.

Preclinical models (in vivo) Standardised,

validated, qualified, etc.

In silico models Standardised,

validated, qualified, etc.

Tools (diagnostic)/assays

Standardised,

validated, qualified, etc.

Patient reported outcomes

Standardised,

validated, qualified, etc.

Modelling and Simulation

technologies

Standardised,

validated, qualified, etc.

New drug targets

Discovered, validated,

qualified, etc

Novel hit and

lead molecules

Novel clinical protocols

New disease related definitions

Other (specify)

Infrastructure (operations)

Patient registries/cohorts

Number of patients

included

Clinical Networks Number of centres

Biobanks Number of samples

Other (specify)

10

'Big data' solutions to leverage knowledge 12

Number/size and type

Comments / Resource location and

identifier, future maintenance

Provide unique identifier, DOI or data citation

Databases size Data citation including Data model description, data quality description, interoperability throug h format and content standards

New data collection

# of studies with new data collection Data Citation

Harmonization of existing data

from multiple sources (pooling) # of data fields reviewed and harmonized

Data Citation

Linking different databases (linked

data) 13 number of data & information sources linked Data Citation

Software applications

# deployed /# releases / #newly developed Please specify internal / public

Validated, Data Citation

Mathematical/Statistical Model

Repositories for reuse # of models curated and

loaded Data Citation

Other (specify)

Implementation of Standards

Number/size and type

Comments / Resource location and

identifier, future maintenance

Provide unique identifier, DOI or data citation

Data Format and Content

Standards and Vocabularies

(including ontologies) adopted/adapted or developed; references

Data Citation; In collaboration with a standards

development organization (e.g. CDISC) Yes/NO

Have the standards and vocabularies been

cited in project publications? yes/no

Standard Operating Procedures

# developed; application area Data Citation; Are the procedures Findable/ Accessible / Reusable)?

Other (specify)

12

Any record which can be used to support a scholarly research argument. The term "data" is meant to be broadly

inclusive with the exclusion of digital manifestations of text. Data refers to forms of data and databases that are not

self-describing -- that require the assistance of metadata, computational machinery and/or software in order to be

useful, such as various types of laboratory data including spectrographic, genomic sequencing, and electron

microscopy data; observational data; clinical trial data,quotesdbs_dbs10.pdfusesText_16
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